Vanderbilt Clinical Trials

Low-dose Buccal Buprenorphine: Relative Abuse Potential and Analgesia

Purpose

The goal of this study is to compare the abuse potential of low-dose equianalgesic buccal buprenorphine to a commonly used full mu opioid receptor (MOR) agonist in a highly controlled experimental setting. This is a translational study in which healthy participants are phenotyped for psychosocial and Opioid-Use-Disorder-risk-related metrics. In a within-subjects crossover design, 60 participants will receive a standard postoperative oral oxycodone dose (10 mg), placebo, and 3 different doses of buccal buprenorphine across 5 separate sessions. Quantitative Sensory Testing (QST) will be used to evaluate alterations in pain responsiveness relative to placebo across buprenorphine doses and oxycodone, and will compare abuse potential (indexed by the standard FDA drug liking metric) following equianalgesic doses of the two drugs.

Conditions

Analgesia
Abuse Opioids
Pain

Eligibility

Eligible Ages: Between 18 Years and 65 Years
Eligible Genders: All
Accepts Healthy Volunteers: Yes

Inclusion Criteria

Intact cognitive status and ability to provide informed consent - Ability to read and write in English sufficiently to understand and complete study questionnaires - Age 18-65 - Opioid-naive status (defined as no use of full mu-opioid receptor (MOR) agonist, partial MOR agonist, or mixed agonist/antagonist medications for the prior 3 months by patient report

Exclusion Criteria

Liver/kidney disease - Chronic pain - Current/prior substance use disorder - Pregnancy (to avoid fetal drug exposure, with pregnancy tests conducted to confirm eligibility) - Seizure disorder - Certain psychiatric conditions (severe depression, bipolar disorder, psychotic disorders) - Recent use of medications that may interfere with study drug metabolism - Recent benzodiazepine or opioid use (confirmed via rapid urine screening prior to each lab session) - The presence of any medical conditions felt by the study physician to render participant unsafe - Prior allergic reaction or intolerance to oxycodone, buprenorphine, or their analogs (explicitly including moderate-to-severe nausea or vomiting with prior opioids) - Recent use of marijuana, delta-8 THC, CBD, and similar products - Recent use of kratom - Severe asthma - Long QT syndrome - Parkinson disease - Weight <60 kg

Study Design

Phase: Phase 4
Study Type: Interventional
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: randomized, double blind, double-dummy, placebo-controlled, crossover
Primary Purpose: Other
Masking: Double (Participant, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Buccal Buprenorphine 300mcg and oral Placebo	In randomized order (crossover) across 5 laboratory sessions approximately 5 days apart, participants will receive: 1) Buccal buprenorphine 300 mcg and oral placebo, 2) Buccal buprenorphine 450 mcg and oral placebo 3) Buccal buprenorphine 600 mcg and oral placebo, 4) Buccal buprenorphine 900 mg and oral placebo, 5) oral immediate-release oxycodone 10mg and oral placebo, or 6) buccal placebo and oral placebo.	Drug: Buccal Buprenorphine 300 mcg buprenorphine for 300mcg buccal administration Drug: Oral Placebo Placebo for oral administration
Experimental Buccal Buprenorphine 600mcg and oral Placebo	In randomized order (crossover) across 5 laboratory sessions approximately 5 days apart, participants will receive: 1) Buccal buprenorphine 300 mcg and oral placebo, 2) Buccal buprenorphine 450 mcg and oral placebo 3) Buccal buprenorphine 600 mcg and oral placebo, 4) Buccal buprenorphine 900 mg and oral placebo, 5) oral immediate-release oxycodone 10mg and oral placebo, or 6) buccal placebo and oral placebo.	Drug: Buccal Buprenorphine 600 mcg buprenorphine for 600mcg buccal administration Drug: Oral Placebo Placebo for oral administration
Experimental Buccal Buprenorphine 900mcg and oral Placebo	In randomized order (crossover) across 5 laboratory sessions approximately 5 days apart, participants will receive: 1) Buccal buprenorphine 300 mcg and oral placebo, 2) Buccal buprenorphine 450 mcg and oral placebo 3) Buccal buprenorphine 600 mcg and oral placebo, 4) Buccal buprenorphine 900 mg and oral placebo, 5) oral immediate-release oxycodone 10mg and oral placebo, or 6) buccal placebo and oral placebo.	Drug: Buccal Buprenorphine 900 mcg buprenorphine for 900mcg buccal administration. Note: This arm has been discontinued as of 06/25/2024 and has been replaced with the 450mcg buprenorphine buccal administration arm. Drug: Oral Placebo Placebo for oral administration
Active Comparator Oral immediate release oxycodone 10mg and buccal placebo	In randomized order (crossover) across 5 laboratory sessions approximately 5 days apart, participants will receive: 1) Buccal buprenorphine 300 mcg and oral placebo, 2) Buccal buprenorphine 450 mcg and oral placebo 3) Buccal buprenorphine 600 mcg and oral placebo, 4) Buccal buprenorphine 900 mg and oral placebo, 5) oral immediate-release oxycodone 10mg and oral placebo, or 6) buccal placebo and oral placebo.	Drug: Buccal Placebo Placebo for buccal administration Drug: Oral immediate-release oxycodone 10mg Immediate-release oxycodone for 10 mg oral administration
Placebo Comparator Oral placebo and buccal placebo	In randomized order (crossover) across 5 laboratory sessions approximately 5 days apart, participants will receive: 1) Buccal buprenorphine 300 mcg and oral placebo, 2) Buccal buprenorphine 450 mcg and oral placebo 3) Buccal buprenorphine 600 mcg and oral placebo, 4) Buccal buprenorphine 900 mg and oral placebo, 5) oral immediate-release oxycodone 10mg and oral placebo, or 6) buccal placebo and oral placebo.	Drug: Buccal Placebo Placebo for buccal administration Drug: Oral Placebo Placebo for oral administration
Experimental Buccal Buprenorphine 450mcg and oral Placebo	In randomized order (crossover) across 5 laboratory sessions approximately 5 days apart, participants will receive: 1) Buccal buprenorphine 300 mcg and oral placebo, 2) Buccal buprenorphine 450 mcg and oral placebo 3) Buccal buprenorphine 600 mcg and oral placebo, 4) Buccal buprenorphine 900 mg and oral placebo, 5) oral immediate-release oxycodone 10mg and oral placebo, or 6) buccal placebo and oral placebo.	Drug: Oral Placebo Placebo for oral administration Drug: Buccal Buprenorphine 450mcg buprenorphine for 450mcg buccal administration. Note: This arm has been added to replace the 900mcg buprenorphine buccal administration arm.

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37069

Contact:
Daniel Larach Larach, MD, MSTR, MA
615-322-6033
daniel.larach@vumc.org

More Details

Status: Recruiting
Sponsor: Vanderbilt University Medical Center

Study Contact

Daniel Larach, MD, MSTR, MA
615-322-6033
daniel.larach@vumc.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.